A Prospective Analysis of Biofilm in Urinary Catheters Study

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT01987336
• Lead Sponsor: Southwest Regional Wound Care Center

Brief Summary

To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A 30cc urine sample would also be collected from the same subject, and analyzed.

Detailed Description

After obtaining informed consent, concurrent with the changing of the Foley catheter in the clinic, would be obtaining a 30 cc. sample of urine which would also be fast frozen and stored in a -81 degree freezer until shipped to the Venter clinic on dry ice.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Subject must be 18 years of age.
2. Subject is attending weekly office visits at SW Wound Care Center as an out- patient.
3. Subject must have an indwelling Foley catheter.
4. Subject is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment.
5. Subject is willing and able to comply with all specified care and visit requirements.

Exclusion Criteria

1. Subject refuses to participate in the study. 2. Subject is expected to be non-compliant. 3. Subject is a resident in a nursing home, or institutionalized. 4. Subject is pregnant. 5. Subject has a Legally Authorized Representative

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter.	Over a period of 20 weeks	the proteomics, metabolomics and metagenomics ("omics") data will be analyzed and integrated in order to understand the microbial population dynamics and the interactions with the human subject host responses which may include antibacterial defenses, local inflammation, immune tolerance towards bacteria

Trial Locations

Locations (1)

Southwest Regional Wound Care Center; 🇺🇸 Lubbock, Texas, United States